This study evaluates the efficacy of alpha-lipoic acid combined with myo-inositol, with or without metformin, in improving menstrual regularity and ovulation in non-diabetic women with polycystic ovary syndrome (PCOS). The study also assesses metabolic, hormonal, and clinical outcomes.
This is a prospective randomized controlled parallel-group clinical trial evaluating the effects of alpha-lipoic acid combined with myo-inositol, with or without metformin, in women with polycystic ovary syndrome (PCOS). A total of 180 patients will be randomized into three groups: Myo-inositol with folic acid Myo-inositol + alpha-lipoic acid Myo-inositol + alpha-lipoic acid + metformin The study duration is 6 months. Outcomes include menstrual regularity, ovulation rate, hormonal parameters, metabolic markers, and clinical signs of hyperandrogenism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Myo-inositol administered orally at a dose of 2 g twice daily for 6 months.
Folic acid administered orally at a dose of 200 micrograms twice daily for 6 months.
Alpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months.
Faculty of Medicine, Cairo University
Cairo, Cairo Governorate, Egypt
RECRUITINGOvulation Rate
Ovulation confirmed by mid-luteal serum progesterone level greater than 3 ng/mL or ultrasound-confirmed follicular rupture.
Time frame: From baseline to 6 months
Menstrual Cycle Regularity
Proportion of participants achieving menstrual cycle regularity, defined as cycle length between 21 and 35 days for at least two consecutive cycles during the study period.
Time frame: From baseline to 6 months
Serum Prolactin Levels
Change in serum prolactin levels measured in ng/mL using standard laboratory assays.
Time frame: Baseline, 3 months, and 6 months
Body Mass Index (BMI)
Change in body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline, 3 months, and 6 months
Serum Triglycerides
Change in fasting serum triglyceride levels measured in mg/dL.
Time frame: Baseline, 3 months, and 6 months
Low-Density Lipoprotein (LDL) Cholesterol
Change in serum LDL cholesterol levels measured in mg/dL.
Time frame: Baseline, 3 months, and 6 months
High-Density Lipoprotein (HDL) Cholesterol
Change in serum HDL cholesterol levels measured in mg/dL.
Time frame: Baseline, 3 months, and 6 months
Fasting Blood Glucose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Metformin administered orally starting at 500 mg once daily and titrated over two weeks to a maximum dose of 1500 mg/day (500 mg three times daily), taken after meals for 6 months.
Change in fasting blood glucose levels measured in mg/dL after an overnight fast.
Time frame: Baseline, 3 months, and 6 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Change in insulin resistance calculated using the HOMA-IR index based on fasting glucose and insulin levels.
Time frame: Baseline, 3 months, and 6 months
Testosterone
Change in serum testosterone levels measured in ng/dL.
Time frame: Baseline, 3 months, and 6 months
Serum Luteinizing Hormone (LH)
Change in serum luteinizing hormone levels measured in mIU/mL using standard laboratory assays.
Time frame: Baseline, 3 months, and 6 months
Serum Follicle-Stimulating Hormone (FSH)
Change in serum follicle-stimulating hormone levels measured in mIU/mL using standard laboratory assays.
Time frame: Baseline, 3 months, and 6 months